OIG Updates the Self-Disclosure Protocol: Key Changes

On November 8, 2021, the Office of Inspector General (“OIG”) issued multiple updates to the Health Care Fraud Self-Disclosure Protocol (“SDP”), incorporating legal changes made since the previous SDP revision in 2013. The OIG’s updated SDP may be accessed here. Below is an overview of the updates.

By way of brief background, the SDP provides a process for people to voluntarily identify, disclose, and resolve instances of potential fraud involving a Federal health care program for which the disclosing party may be liable for. The SDP provides guidance regarding how to investigate health care fraud, quantify the damages of health care fraud, and how to report such conduct. The SDP provides the opportunity to avoid costs and disruptions often associated with Government-directed investigations and civil/administrative litigation.

Increased Minimums to Settle

OIG updated the minimum settlement amounts for the SDP to align them with new statutory minimum penalty amounts. This resulted in increases to the minimum settlement amounts under the SDP. For example, the minimum settlement amount for kickback-related submissions has been increased from $50,000 to $100,000. The OIG increased the settlement amount for all other SDP matters from $10,000 to $20,000.

Disclosure of Damages

The updated SDP requires disclosures to include an estimate of the amount of damages caused to each Federal health care program and a sum of all damages caused to all Federal health care programs relevant to the disclosed conduct. Alternatively, the disclosing party may include a certification in the disclosure that they will complete and submit the estimation within ninety (90) days of submission. However, note that if the disclosing party is capable of determining the actual amount of damages caused to Federal health care programs, the disclosing party must provide the amount of actual damages rather than an estimate.

SDP Submissions through OIG Website

The OIG also updated the SDP to require all disclosures to be made through the OIG’s website at https://oig.hhs.gov/compliance/self-disclosure-info/provider-self-disclosure-protocol/. Previously, the OIG accepted disclosures submitted by mail. Moving forward, all disclosures must be made online through the OIG’s website.

Separate Self-Disclosure Programs for HHS Grants and Contractors

Further, the OIG clarified that disclosures related to HHS grants or contracts should not be disclosed under the SDP. Instead, the OIG has developed separate self-disclosure programs for these types of disclosures. All HHS grant recipients seeking to submit a self-disclosure should read the guidance available on the OIG’s Grant Self-Disclosure Program website, which includes a separate HHS Grant Self-Disclosure Form. Similarly, OIG has developed a self-disclosure program for HHS contractors. For more information and guidance on submitting a Contractor self-disclosure, see the OIG’s Contractor Self-Disclosure Program website.

Department of Justice (“DOJ”) SDP Authority

The OIG further clarified that it would coordinate with the DOJ to resolve SDP matters and cases involving potential criminal conduct. As updated, the SDP provides that the DOJ may participate in SDP matters when it chooses to or when the disclosing party requests release under the False Claims Act (“FCA”). However, if the OIG is the sole agency representing the Federal Government, the matter will be settled in accordance with OIG’s CMP authorities. Otherwise, if the DOJ becomes involved, the OIG will advocate for the disclosing party to receive a benefit from disclosure, but the matter will be resolved as the DOJ determines is appropriate and consistent with its resolution of FCA cases. The OIG will also refer any cases involving the disclosure of criminal conduct to the DOJ for resolution.

Parties under a Corporate Integrity Agreement (“CIA”)

Lastly, the OIG updated the SDP to require each disclosing party under a CIA to reference the fact that it is subject to a CIA in its disclosure and to send a copy of its disclosure to its OIG monitor. OIG clarified that any SDP disclosure constituting a reportable event, as defined by the CIA, must be reported to OIG.

For more information on the issues relating to this article, please contact Adrienne Dresevic, Esq. at adresevic@thehlp.com or the Health Law Partners at (248) 996-8510 or (212) 734-0128 or by email at partners@thehlp.com.